Study Evaluating Effects of CX-3543 in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

Inclusion Criteria

• •Patients with B-cell CLL with indications for treatment by National Cancer Institute (NCI) Working Group criteria.
• •Measurable disease (lymphocytes ≥ 5,000/microliter, or palpable lymphadenopathy or bone marrow involvement \> 30%).
• •Males and females 18 years of age or older.
• •Received a minimum of one prior purine analog-based chemotherapy regimen (e.g., fludarabine, cladribine, or pentostatin) and one monoclonal antibody therapy (e.g., Campath or Rituxan) but ≤ 4 chemotherapy regimens.
• •Patients must have central intravenous (IV) access, or agree to the insertion of a central line.
• •All previous cancer therapies, radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to the start of treatment. Any cytotoxic chemotherapy must have been discontinued 28 days prior to the start of treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1 above baseline.
• •Normal oxygen saturation with pulse oximetry on room air.
• •Hemoglobin ≥ 9 gm/dL (may be post-transfusion).
• •Platelet count ≥ 25,000/microliter.
• •Total bilirubin \< 2 X upper limit of normal (ULN), and ALT and AST \< 2 x ULN.
• •Serum creatinine within normal limits OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above the upper normal limit for the institution
• •ECOG Performance Status ≤ 1.
• •Anticipated survival of at least 3 months.
• •For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
• •Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return to the clinic for required assessments.